| Primary Device ID | 37332414106936 |
| NIH Device Record Key | 75a31da4-0c99-4937-9f04-d400414c5163 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MARS Monitor |
| Version Model Number | 800437 |
| Catalog Number | 800437 |
| Company DUNS | 354021099 |
| Company Name | GAMBRO AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| medinfo_medproducts@baxter.com |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing. |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Atmospheric Air Pressure between 500 and 1060 millibar, Relative Humidity is non-condensing. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 37332414106936 [Primary] |
| FLD | Apparatus, Hemoperfusion, Sorbent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-06-08 |
| 37332414127214 - CLCA - CLEANCART A | 2023-12-11 CleanCart A |
| 37332414127221 - CLCC - CLEANCART C | 2023-12-11 CleanCart C |
| 07332414124519 - AK 98 | 2021-03-30 Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body |
| 07332414126766 - PRISMAFLEX | 2019-03-11 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an |
| 37332414107728 - MARS TREATMENT KIT TYPE 1116/1 - X-MARS US | 2019-02-13 The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with |
| 37332414106950 - Mars Treatment Kit | 2018-07-06 The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing |
| 37332414088317 - BiCart | 2018-07-06 Sodium Bicarbonate for Hemodialysis |
| 07332414105266 - Prismaflex | 2018-07-06 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an |